Andhra Pradesh: VIMS to conduct intranasal COVID vaccine trials
Visakhapatnam: Visakha Institute of Medical Science (VIMS) is one of the ten volunteers and the only institution in Andhra Pradesh to start human clinical trials of COVID-19 intranasal vaccine (BBV154).
Bharat Biotech has provided all the required facilities needed to run the trials. Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company headquartered in the city of Hyderabad and has in-licensed technology from Washington University in St Louis.
To check for vaccine-induced immunity, these study patients will undergo regular physicals and laboratory tests before and after the dosages are administered as part of the study and its goal is to assess the nasal vaccine's immunogenicity, safety, reactogenicity, and adverse events of particular interest.
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Speaking to TOI, VIMS director Dr. K Rambabu said "The vaccine will stimulate both systemic and mucosal immune responses. This means that the vaccine can create an immune response in the nose, which may help in the prevention of infection as well as transmission of the pandemic virus."
"The study will evaluate the broad immune response of the intranasal vaccine - neutralizing IgG, mucosal IgA, and T cell responses. The volunteers will be subject to various tests to determine vaccine efficacy, which is essential to deal with the continually evolving pandemic situation," he added.
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The intranasal vaccine's immunogenicity and safety will be compared to Covaxin in 3160 volunteers aged 18 to 65 at 17 hospitals across India, including two in Telangana - NIMS and Malla Reddy Hospital - as well as AIIMS in Delhi and Patna.
At nine hospitals, including AIIMS in Delhi and Patna, the Phase-III trial is being done to assess the immunogenicity and safety of a BBV154 booster dose in 875 volunteers aged 18-65 years who have previously been vaccinated with Covaxin and Covishield.
Hospitals in Karnataka, Maharashtra, Chhattisgarh, UP, Goa, Haryana, Rajasthan, Hyderabad, Nagpur, Belgaum, Bengaluru, Gorakhpur, Kanpur, Faridabad are also participating in the trial.
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